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ISO 9001 Audit Report

* Example Report *

North America +1-813-252-4770

Latin America

+52-1-333-2010712

Europe & Middle-East +49-8122-552 9590

Asia & Asia Pacific +886-2-2832-2990

Email

[email protected]

www.proqc.com

8

PURPOSE: Audit scores are rarely understood outside of the quality organization or the auditing company. This audit is based on defined criteria for each element audited. Scoring is based on the supplier's ability to meet the requirements. The audit focuses on factors that would result in increased costs or financial loss to the client due to poor performance by the supplier. The ISO 9001 based audit is useful for making sourcing decisions and reducing associated risks.

SCORING:

ISO 9001 Quality System Audit Rev.GUIDELINES

Scores are assigned based on what is done for the Pro QC client regardless of what is done for other clients. For example, if control plans are developed for other clients but not for the Pro QC client, the score must be NC. Scoring must be explained to the supplier at the opening meeting.

Complies with the Requirements = CImprovement Needed = INon-Conformance Found = NCN/A = Does Not Apply

GUIDELINE FOR SCORING CONFORMANCE:Each question is assessed for conformance to the requirements of ISO 9001, and the auditors knowledge of the product and/or process This must be clear to the supplier at the opening meeting.

Complies with Requirements = - Has objective evidence to support the question, and - Has a written procedure (when required).

Improvement Needed = - Has objective evidence, but procedure needs improvement. - Has objective evidence, but no written procedure. - Has written procedure, but is lacking some objective evidence to support the question.

Non-Conformance = - No objective evidence to support the question (regardless of the procedure). - Lacking some objective evidence and no written procedure.

The auditor should review the audit results with the supplier, but cannot provide the supplier a copy of the audit. The audit is the property of the client.

CORRECTIVE ACTIONS:It is recommended that the client request a corrective action (improvement plan) based on the results of the audit. The improvement plan should include the following: - Detailed description of action plan. - Name of the person responsible for the improvement activity. - Date when the improvement will be completed.

RESULTS/RECOMMENDATIONS: (Automatically Calculated)The score is based on the percent of questions that Complies with Requirements, percent that Needs Improvement, and the percent that have a Non-Conformance. Each client should review how the supplier was evaluated for each question and base their decisions on factors that are important to their organization and product(s).

AUDIT REPORT:The following sections are completed by the auditor: - Scope of the Audit - Recommendations - Strengths of the Supplier's Quality System and Manufacturing Process - Opportunities for Improvement (Weaknesses in the Supplier's Quality System and/or Manufacturing Process)

RESULTS REVIEW WITH SUPPLIER:

8

NAME : NAME :

ADDRESS : ADDRESS :

CITY : CITY :COUNTRY : COUNTRY :

PHONE : PHONE :FAX : FAX :

Mr./Mrs. Title: Email:










Scope :

Nb. Ques. %

93 85.3% 16 14.7%

0 0.0%

5

109

request immediate corrective action in case of long-term business.

There are serious major issues with this supplier that could impact your business.The better solution will be to source from another supplier.

AUDIT RESULTS

RECOMMENDATIONS

supplier, and keep pushing for improvements.

System has several major issues,but you could temporally use this supplier and

Systems are effective. You could start or continue business with this supplier

System is acceptable, with minor nonconformities. You could use this

Improvement Needed ( I )

Not Applicable (N/A)

XX/XX/XXXX XXXXXXX

XXXXXXXXXXX XXXXXXXXXXXXXX

XXXXXXXXXXXXXX

XXXXXXXXXXXXXXXXXXXXXX

XXXXXXXXXXXXXX

XXXXXXXXXXX

PRO QC PERSONNEL PARTICIPATING

XXXXXX

XXXXXXXXXXXXXX

Supplier Name Audit Date

XXXXXX

XXXXXXXXXXXXXXXXXXXXXX

ISO 9001 Quality System Audit Rev.SUMMARY

Report No.

XXXXXXXXXXX XXXXX

XXXXXXXXXXXXXX

XXXXXXXXXXXXXX

XXXXXXXXXXXXXX

XXXXXX XXXXX

XXXXXXXXXXX

CLIENT'S INFORMATIONSUPPLIER'S INFORMATION

XXXXXXXXXXX

XXXXX

SUPPLIER'S PERSONNEL PARTICIPATING

Non-Conformance w/ Requirements (NC)

XXXXXX XXXXXXXXXXXX XXXXXX

Complies with Requirements ( C )

Category

XXXXXX XXXXXX

XXXXXX XXXXXXXXXXX XXXXX

85.3%&

14.7%&

0.0%&

8ISO 9001 Quality System Audit Rev.

AUDIT REPORT

The intent of conducting a quality system audit based on ISO 9001 requirements is to provide the client with information useful for making an initial assessment about business viability and reducing their associated sourcing risks.

Supplier Name Audit Date Report No.XXXXXXX

Summary/Recommendation:

Scope of Audit:

XXXXXXXXXXX XX/XX/XXXX

The audited supplier was founded at the beginning of 2010 by XXXXX and is located in XXXXX.The factory has 61 employees involved in the design and manufacturing of leather insole, latex Iinsole, comfortable insole and gel insole, with an estimated 50% market share in the EU. The product is fully completed in the surface ofabout 4,000 square meters.

The factory has recently established a complete Quality Management System in respect to ISO 9001. The system is

Strengths:

inspection, in-process inspection to pre-shipment inspection. They are in the process of applying for ISO 9001 certificationwithin the next three months.

The team is dedicated to the mission according to ISO 9001.

currently running since March 20XX, with effective records starting from the design, supplier selection, incoming

We recommend this factory as a reliable supplier for future partnership.

1. Team is dedicated to satisfying client expectations through respect of the ISO 9001 standard.2. Adequate equipment exists to ensure reliability and consistency in the manufacturing process.3. Clear lean manufacturing, with visible description of quality goals.4. Excellent defect description on-site with clear visual photos.5. Effective defect management with red boxes available at each location for storage.6. Availability of standard (golden sample) for visual comparison.

1. Develop procedure as a guideline for the implementation of management review.2. Add a technical person from Quality, Production or Design to be part of the Internal Auditor Team.3. In the annual training plan, add detail of the training evaluation method and related independent appraisers.4. Develop a standard test examination template to use for written test after training.5. Define the type of monitoring or control to apply to each supplier base in evaluation performance.6. Document reaction plans for operator to implement in case deviation is observed in process / product.

Opportunities for Improvement:

7. Develop s system for verification of tooling / fixture before and after use, or after certain number times used.8. Develop an effective annual maintenance plan for machine / testing equipment and implement it accordingly.

8

SCORE

B1B1.1

C

B1.2

C

B1.3

C

B1.4

C

B1.5

C

B1.6

C

B1.7

I

B1.8

C

FINDINGSQUESTIONNAIRE

Yes, there is Management Representative nominated in the name of XXXX. Her nomination letter is visible in the Quality Manual SS1-Q1-2013. See photo #4.

No, the factory does not have a quality management review procedure. However, they have conducted a management review on xx/xx/xxxx, and recordings of input and output are available.

Yes, there is an organization chart documented in the Quality Manual SS1-Q1-2013, in page #23. See photo #3.

Yes, the factory has about 60 employees, and equipment are available, see detail in factory Profile.

Is there an individual been assigned the roles of Management Representative?

Is there a documented management review procedure and is it under revision control. Where is the most recent management review conducted? Does it demonstrate the suitability and effectiveness of the Quality System? Does the review cover all the required topics specified in the Quality Manual and/or management review procedure?

Are quality system procedures & work instructions documented and identified in a documented outline of the quality system structure?

Rev.AUDIT CHECKLIST


C = Complies with Requirements, I = Improvement Needed, NC = Non Conformance, N/A = Not Applicable

Report No.

ISO 9001 Quality System Audit

XX/XX/XXXX

Is there an company organization chart and does the organization define quality roles & responsibilities at the individual level?.

Management Responsibility

XXXXXXX

Are the Organization Quality Goals & Objectives documented? Are Quality Objectives measurable and consistent with the quality policy?. (Take a photo)

XXXXXXXXXXX

Yes, the quality system procedures & necessary work instructions are documented and identified in the Quality Manual SS1-Q1-2013.

Are adequate resources (manpower, equipment, workshops, etc.) provided for quality activities?

Yes, the factory has a quality policy stated in Quality Manual SS1-Q1-2013, in page #6, and also publishes it in various places in the workshops and offices. See photo #1.

Yes, the factory quality goals & measurable objectives are documented in the Quality Manual SS1-Q1-2013, and are also visible at various workshops and offices. There are: 1. Customer satisfactory to reach 80 points. 2. External complaint not to exceed 3 cases / year. 3. First time yield > 95%. . 4. External conformity rate > 99%. See photo #1.

Yes, the factory has defined 15 procedures as guideline to meet Quality Objectives. They are monitored, for example, on customer satisfactory (yearly), suppliers conformity (monthly). production defect rate (weekly). See photos #1 and #2.

Is the quality policy statement clearly posted and is the policy communicated and understood throughout the organization? (Take a photo of where the policy is posted)

Does the organization define a plan or strategy to meet the Quality Goals and Objectives? Are Quality Objectives monitored and reviewed at reasonable intervals?

8

SCOREFINDINGSQUESTIONNAIRE

Rev.AUDIT CHECKLIST



Report No.


XX/XX/XXXX XXXXXXXXXXXXXXXXXX

B2

B2.1

C

B2.2

C

B2.3

I

B2.4

C

B2.5

C

B2.6

C

B3

B3.1

C

B3.2

C

B3.3

I

B3.4

C

B4

B4.1

C

Yes, training record are maintained. See photo #8.

Does employee training include the awareness that defects may occur from improper performance of their specific jobs? Specify the types of defects and related training received.

Is there a design procedure documented under revision control?.

Yes, the factory has two internal and certified auditors, all are office peoples. See photo #6 . Will recommend to have addition auditor from technical team (Design, Quality or Production).

Yes, audit scope and plan covering all requirements is documented in form QR2-09-02. See photo #5.

Has the effectiveness of training been evaluated trhough any type of examination or test?

Yes, there is a procedure for design process SS2-06-2012, A/0.

Design Control ( Mainly for the process to use for the manufacturing of the product)

Does the audit plan/scope address all areas covered by the quality systems & cover all requirements regarding regulations?

Are the results of internal audits reviewed by managers responsible for the area audited?

Are audit findings properly documented and is there evidence of actions taken?

Has the organization identified training needs and developed a documented training plan?

Are individual training records well established and properly maintained?

Yes, the factory has training plan for the year XXXX, documented in file QR2-03-02 with 14 training topics. See photo #8.

Personnel (Training)

Is there a documented procedure controlling internal audits? Is the audit procedure contains a provision for re-audits?

Have the quality system audits have been scheduled & completed and audit documents are on file?

Are internal auditors trained and are they independent of the areas audited?

Yes, the findings were recorded in the form QR2-09-04, 2 findings were found such as 7.5.3 / 4.2.4 and 7.5.5.

Yes, the last audit was conducted on June 10th, according to the plan documented in QR2-09-01. See photo #5.

Internal AuditYes, the factory has procedure SS2-09-2013, revision A/0 as guideline for internal audit.

There is no record of evidence that effectiveness of the training was conducted, and methods used to evaluate are not clearly mentioned in the training plan.

Yes, the training topic #6 were related to quality inspection of specific defects. Additional defect description are posted at each workstation as daily training material. See photo #9.

Yes, the findings were recorded in the form QR2-09-04, 2 findings were found such as 7.5.3 / 4.2.4 and 7.5.5.

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Rev.AUDIT CHECKLIST



Report No.



B4.2

C

B4.3

C

B4.4

C

B4.5

C

B4.6

C

B5

B5.1

C

B5.2

C

B5.3

C

Yes, design input are defined in the document QR2-06-03, for example of the project range size 35# - 45#. See photo #11.

Yes, the design planning is documented in QR2-06-02. See photo #10, for example of the project range size 35# - 45#. See also photo #11.

Are the design input documentation requirements clearly explained in a revision controlled procedure? (Write the Doc # and Rev. # ) Is design input documented under revision control, up to date, and has been reviewed and approved?

Are design output content, format and design output approval methods defined in a revision controlled procedure? Do design outputs include acceptance criteria?

Document ControlIs there a documented procedure in place that describes approval, distribution and change control for internal documents?

Are appropriate documents available at all locations where they are used?

Is there evidences that approval, distribution and change is being followed in internal documentation?

Yes, the factory maintains a list of distribution and change followed in document QR2-01-01.

Yes, the factory has procedure SS2-01-2013, A/0 as guideline for the control of documents.

Yes, design output are defined in the document QR2-06-04, for example of the project Range size 35# - 45#. See photo #11.

The auditor cross checked two documents on-site, and found out that all documenst are properly distributed as it was recorded in QR2-01-01.

Record of review are conducted and signature of related authority, including testing results from external testing centers.

It is defined in the procedure.

Are the design planning requirements clearly explained in a revision controlled procedure? (Write the Doc # and Rev. # ) Does the referenced design plan include significant elements such as design reviews, verification & validation, including responsibilities / interfaces?

Are reviewed and approved documents available to demonstrate that the design output has satisfied the design input. in other words, parameters are traceable from input to output? (Take photo of record)

Is the procedure that defines & controls formal design reviews specific when reviews are required, participants, decisions made, and follow-up actions required? Are formal design reviews performed? Does documentation include all elements required by the procedure?

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Rev.AUDIT CHECKLIST



Report No.



B5.4

C

B5.5

C

B5.6

C

B5.7

C

B5.8

C

B6

B6.1

C

B6.2

C

B6.3

C

B6.4

C

B6.5

I

Yes, the auditor checked supplier # 8, 17 and 32 from the master list, and they have record of evaluation. See photo #14.

The type and extent of control to apply in each supplier is not properly defined in supplier list QR2-07-02. However, raw material received from hjose suppliers are inspected at incoming inspection step and records are available.

Is there documented evidence that suppliers have been evaluated for approval?

Yes, the master list is documented in the file QR2-01-01. See photo #12.

Yes, the factory has procedure SS2-01-2013, A/0 as guideline for the control of documents.

Yes, the factory has a procedure SS2-07-2013, A/0 as guideline for supplier evaluation and selection.

Yes, acceptance criterias is defined in the procedure, section 4.1.2 and also in the Supplier Evaluation Form QR2-07-01.

Yes, the factory has a list of 50 qualified suppliers listed in the file QR2-07-02. See photo #13.

Purchasing

Is a documented procedure in place that describes control for external documents and is there evidence that it is being followed?

Is there a documented procedure defining supplier evaluation and approval?

Are acceptance requirements for acceptable suppliers clearly defined?

Is there a list of approved suppliers of product related parts, services, consultants, subcontract, etc.

Is there is a master list of all controlled documents that includes current revision and distribution information?

Yes, changes are communicated in a timely manner by office people in change to ensure that each person has an updated document.

Are all obsolete documents removed or otherwise prevented from unintended use? How does the organization plan to prevent their unintented use?

Are changes to the documents reviewed and approved by an individual in the same function or organization that performed the original review and approval? Are change records maintained and they include a description of change, signature of approving individual(s), approval date, and effective date?

Are approved changes communicated to the appropriate personnel in a timely manner?

The QMS just started to be implemented in March this year. There are no obsolete documents yet. But, the procedure SS1-01-2013 is planned to maintained as described in the section 4.6.2.

Yes, creation or change are reviewed and approved by an individual authority who is Management Representative, XXXXX. Her signature if visible in each document.

Are there a documented procedures that define the type and extent of controls being applied to suppliers (i.e. source or receiving inspection, surveillance audits, test data/reports, etc.)

8


Rev.AUDIT CHECKLIST



Report No.



B6.6

C

B6.7

I

B6.8

I

B6.9

C

B7

B7.1

C

B7.2

C

B7.3

I

B7.4

C

B7.5

C

Yes, it written in the procedure. Conflict issues are solved by email or oral communication with client. No record available.

Contract / Order Review

Does the contract review procedure define review of orders (contracts) before acceptance/approval per documented criteria for all orders? Is there is evidence of proper implementation?

Does the contract review procedure define how to resolve order conflicts/errors/etc.? Is there evidence of proper implementation?

The contract review procedure defines how order changes are processed/approved. There is evidence of proper implementation.

Does the contract review procedure define the processes used to assure order commitments can be and are met on time, completely. There is evidence of proper implementation. (Take photo of the record)

Yes, the factory has the procedure SS2-05-2013. A/0, section 4.2. Records are written in the form QR2-05-01, Example of client XXXX. See photo #16.

Yes, records are written in the form QR2-05-01, Example of client XXXX. See photo #16.

Yes, it written in the procedure. Conflict issues are solved by email or oral communication with client. No record available.

Changes in contract are recorded in form QR2-05-03.

Yes, supplier's performance are evaluated monthly based on the quality level, On-time delivery, after service reply of number of lot delivered. The result is recorded in a document (No document number). See photo #15.

There is an agreement approved by both parties and dispached for each single order. The auditor checked an example of the PO #2801, order number 1200038. It does not contains a written agreement about communication in case of change.

Communication and approval are done mainly by email or telephone, not a document that can be saved to prove the evidence.

Yes, it required to supplier to fax back purchasing orders with their stamp to demosntrate their understanding and approve to meet the requirement of the order or changes.

Is there an agreement with the supplier that supplier agrees to notify customer of changes to the product or service so that the affect of the change on quality of the finished device can be evaluated?

Is there a process/procedure that requests to review and implement change requests made by suppliers and/or customers?

Is there a process that ensures that purchase order content, product requirements and supplier contracts, including changes, are approved?

Is there a written procedure that defines contract (customer order) review process? Is there evidence of proper implementation?

Is there a procedure defining means to monitor supplier performance and the need for re-assessment and/or corrective action? There is evidence of implementation. Data relating to supplier performance review is communicated to supplier. (Take photo of supplier performance)

8


Rev.AUDIT CHECKLIST



Report No.



B7.6

C

B8

B8.1

I

B8.2

C

B8.3

C

B8.4

I

B8.5

C

B8.6

C

B8.7

C

B8.8

C

Yes, there are work instructions posted on-site, see for example SS3-07-2013(03). See photo #17.

Yes, for example of temperature of machine that can affect the qualitty of adhesive between elements. See photo #18.

There is a procedure in place that defines the requirements for the verification and validation of manufacturing process changes.Is there evidence that manufacturing process changes have been verified and/or validated following procedural requirements?

Do documented quality plans exist for various products manufactured (process flowchart with tests / control or inspections plan) and are correctly followed?

Production and Process Controls

Yes, following records are retained: Order Review (QR2-05-01) Production Schedule (QR2-05-02) Order Modification (QR2-05-03)

Yes, the production monitoring procedure is documented in SS2-08-2013. The flow chart is also visible, but no document number for its identification and control.

Are production process work instructions documented and are they correctly followed?

Where process variation can effect product specifications, are there processes in place to monitor the variation and take action to maintain or reestablish control?

Does the contract review procedure define what records are retained, how, and where? These records are readily accessible and accurate.

If process control limits have been exceeded, is it clearly defined what actions should be taken and how actions will be documented?

If reference standards are referenced in process documents, are the standards available, current and under revision control?

Is there evidence demonstrating that process or process equipment changes are approved in accordance with a documented procedure?

Have workmanship standards been identified and representative samples identified, approved and controlled?

The action to take in such case are not clearly documented and available for operator.

Yes, workmanship standards are defined in form of defective photos to avoid. See photo # 9. Reference samples are also available on-site at each workstation, including packaging process. See photos #17, #19 and #20.

Yes, refences samples are availablel on-site at each workstation, including packaging process. See photos #17, #19 and #20.

Yes, evidences are available for changing in process.

Yes, there are work instructions posted on-site. See for example SS3-07-2013(03), photo #17, that defines verification and validation.

8


Rev.AUDIT CHECKLIST



Report No.



B8.9

N/A

B8.10

N/A

B8.11

C

B8.12

I

B8.13

I

B8.14

C

B9

B9.1

C

B9.2

C

B9.5

C

Specific environment is not required.

Yes, each tooling has identification of the size or name of product to use, including for the client. See photo #22.

All processes are validated, and records are available.

Yes, there are records of first piece inspection to release a start up for production.

Is there evidence of approval and sign-off for production release of processes and equipment including a V&V summary report/release letter?

Specific environment is not required.

Yes, facility has adequate and enough space, with every thing located in the right place. See photo #21.

Process Validation

If limitations of application or range of use apply to production equipment, are these limitation be clearly documented and posted or readily available?

Is there is a procedure that defines when process validation is to be done (non-verifiable/special processes)and process controls/monitoring defined? There is evidence of implementation.

For validated processes, is the monitoring and control methods and data, the date performed, and where appropriate the individual(s) performing the process is documented?

Verification of equipment are conducted in daily basis, and are recorded and aintained in the machine. Tools and fixtures are not verified before and after production.

The factory does not have a clear periodical maintenance pla documented. But, they have a record of previous maintenance conducted.

When controlled environments are required, are requirements for monitoring and control specified and applicable records available to demonstrate conformance?

Is there evidence of training for employees regarding environmental controls when they work in such areas even if only temporarily?

Are buildings and facilities adequate in regard to space, neatness, cleanliness, contamination control?

Are there procedures that define verification requirements to insure that equipment, tools and fixtures used in the manufacturing process meets specified requirements? There are records demonstrating that tools and fixtures have been verified to meet their design requirements prior to being released for production use.

Are there procedures that define maintenance and adjustment requirements for production equipment? Are appropriate records maintained and equipment inspected per a plan?

Yes, records are well maintained. See photo #23.

8


Rev.AUDIT CHECKLIST



Report No.



B10

B10.1

C

B10.2

N/A

B10.3

C

B10.5

C

B10.6

C

B11

B11.1

I

B11.2

C

B11.3

C

Calibration is conducted by external National Institute for Calibration and not done internally.

Are there specification documents (approved and controlled) available for calibration of inspection, measurement and test equipment?

Yes, the factory maintains a master list of inspection equipment, and all have calibration expiration dates and certificates. See photo #24.

Inspection, Measuring and Test EquipmentIs there a master list of inspection, measurement and test equipment�in which the calibration date and expire date are clearly stated?

Yes, there are clear work Instructions for implementation of incoming inspection. See file SS3-02-2013 defining product characteristics to check for each type of material. And record of inspection are maintained in form QR2-09-01, for example Lot Number A1203120504. See photo #25. Although they claim to apply sample plan GB2828, it does not specify the proper sample size and acceptance level (AQL).

Acceptance Activities

Are there procedures that define verification requirements for tools/fixtures/equipment used for inspection, measurement or test? Is there evidence of these verifications being done?

Yes, procedures are defined and records are maintained. See photo #24.

Are there procedures that define acceptance activity (inspections, tests, verifications) and record keeping requirements for incoming product and material? Is there evidence of compliance?


Are there specific equipment calibration instructions and records of calibrations performed (when and by whom)??

Are records available to demonstrate that such equipment is calibrated, labeled, and within defined intervals?


Yes, there are work Instruction that define acceptance for processes and product characteristics, in SS3-03-2013, and there is evidence of implementation. See records in photos #26 and #23.

Yes, there are work Instructions that define acceptance for final inspection from product characteristics, in SS3-04-2013, an there is evidence of implementation. See records in photo #27

Are there procedures that define acceptance activity (inspections, tests, verifications) and record keeping requirements for in-process product? Is there evidence of compliance?

Are there procedures that define acceptance activity (inspections, tests, verifications) and record keeping requirements for final product? Is there evidence of compliance?

8


Rev.AUDIT CHECKLIST



Report No.



B11.4

C

B11.5

C

B11.6

C

B12

B12.1

C

B12.2

C

B12.3

C

B12.4

C

B12.5

C

B13

B13.1

C

Is there procedure that defines the identification of product and materials at receiving and incoming inspection. There is evidence of compliance.

Yes, procedures are defined and product has specific area to be stored with labeling. See photo #31.

Identification and Traceability

Yes, there are work Instructions that define acceptance for final inspection from product characteristics, in SS3-05-2013, and there is evidence of implementation. See records in photo #28.

Is release for shipment is authorized by signature and date in compliance with the procedure?

Yes, all such information are visible in each records.

Yes, procedures for identification of product status are available.

Yes, procedures are defined and raw material has specific area to be stored before and after inspection. See photos #21, #29 and #30.

Do acceptance records include the acceptance activities performed, the date of performance, the acceptance result, the equipment used if appropriate as well as the signature of the individual(s) conducting the acceptance activities?

Is there procedure that defines the identification of product and materials in store and there is evidence of compliance?

Are there procedures that define the identification of the acceptance status of product throughout the process, factory to field?

Is there a procedure that defines the marking and identification of non-conforming material? Is there evidence of compliance?

Yes, the factory has a non-conforming material procedure. Defective product is stored in red boxes located at each workstation. See photos #21 and #32.

Nonconforming Product Control

Yes, procedures are defined and product has specific area to be stored with labeling. See photo #31.

Is there a procedure that defines the identification of product and materials throughout the manufacturing process and there is evidence of compliance?

Yes, procedures are defined. For identification of product per lot, and they are traceable from their ERP system.

Yes, there are such procedures for the traceability of lot numbers.

Is there a procedure maintained for identifying each unit, lot, or batch of finished devices and components?

Is there a procedures that describes how product tracking data is to be captured. and is there evidence of compliance?

8


Rev.AUDIT CHECKLIST



Report No.



B13.2

C

B13.3

C

B13.4

I

B13.5

C

B13.6

C

B14

B14.1

C

B14.2

C

B14.3

C

B14.4

N/A

Yes, samples are provided on site as Instruction to show how product should be packaged, see photo

Packaging design was done by the client.

Is there a procedure that defines disposition options and conditions of non-conforming material (scrap, rework, return, use as is, deviate)? Is there evidence of compliance?

Yes, labeling are examinated during packaging and during outgoing inspection, and record are available. Description of defect to avoi din packaging and labeling are visible on site.

Are adequate controls in place to prevent labeling errors or mix-ups during storage, labeling and packaging operations?

Are there procedures / work instructions in place that describe how products are to be packaged for shipment?

Has packaging design been validated and results recorded?

Are there procedures that cover feedback of nonconformance information to the problem source, and there is evidence of compliance?

Yes, rejected product is recorded in a master list QR2-1103. See photos #33 and #34.

Are labels examined for accuracy before they are released for use and are signature and date of the individual performing the examination is documented?

Yes, the factory has non-conforming material procedure. Defective product is stored in red boxes located at each workstation. See photos #21 and #32.

Yes, rejected product are recorded in a master list QR2-1103, see photo #33, to be use for statistical analysis, see photo 34.The data is not communicated to the whole team as part of improvement.

Yes, product can be reworked and be re-inspected.

Yes, labeling are examined during packaging and during outgoing inspection, and record are available. Description of defect to avoi din packaging and labeling are visible on site.

Is there a procedure that describes how re-work will be accomplished and documented and is there evidence of compliance?

Yes, description of the reworking is available.

Labeling and Packaging

Is there procedure that requires evaluation of nonconformities, including documentation of any needed investigation or decision not to investigate and guidance of when to investigate. Evidence of compliance is available.

Is there a physical segregation of nonconforming material during subsequent storage & processing. and there is evidence of compliance?

8


Rev.AUDIT CHECKLIST



Report No.



B15

B15.1

C

B15.2

C

B15.3

N/A

B15.4

C

B16

B16.1

C

B16.2

C

B16.3

C

B16.4

C

B16.5

C

B17

B17.1

I

Quality system record such as audit and findings are maintained by MR.

Quality Records

Are procedures in place that define the content, location, and retention of quality system records? Evidence of compliance is available.

QC records are maintained for at least three years in the QC department.

No such procedure in place.

Are retention periods for quality records equivalent to the design and expected life of the device but not less than two years from date of release to distribution?

Are procedures are in place that define the content, location, and retention of design records? Evidence of compliance is available.

Statistics

Area procedures in place that define the content, location, and retention of process control records? Evidence of compliance is available.

Are procedures in place to identify valid statistical techniques for sampling or product characteristic/process control where necessary?

N/A

Handling, Storage, Distribution

Yes, quality records were available.

Yes, retention period is defined in the record list QR2-02-01, with minimun three years.

Yes, design records are maintaind in the technical department.

Have procedures been established that describes the methods for authorizing receipt from and dispatch to storage areas and stock rooms? And there is evidence of compliance.

Are all quality records readily retrievable during the audit?

Are procedures in place to control material with limited shelf life to prevent expiration or deterioration?

Yes, there are records with authorized signature for the release of product for dispatch to storage areas.

Are there procedures in place that specify material control activity/handling to and from stock locations to assure protection from mix-ups, damage, deterioration, contamination, or other adverse effects? And there is evidence of compliance.

Yes, procedure for handling product during manufacturing are defined and welll followed, product are transported in blue boxes, and each has a label to indicate status.

Yes. Are procedures/practices in place for storage areas that prevent mix-ups, damage, deterioration or other adverse effect? Areas are neat and well organized.

8


Rev.AUDIT CHECKLIST



Report No.



B17.2

C

B17.3

I

B17.4

I

B18

B18.1

C

B18.2

C

B18.3

C

B18.4

C

B18.5

C

B18.6

C

B18.8

C

B18.9

C

Yes, there is a procedure for collection of defect during production, from incoming inspection and from client complaint, and they are all documente.

Yes, it is recorded in photo #33.

Yes, see photo #34 for defect analysis.

Is there a documented and properly implemented process for the collection of defects found by or in the quality system?

Is there a documented and properly implemented process for the collection of production defects?

Is there a documented and properly implemented process for the collection of supplier related defects?

Corrective and Preventive Action

Is there a documented and properly implemented process for the collection of design related defects?

Are those statistical techniques are documented and based on sound statistical methods?

Is a procedure to ensure that sampling methods are adequate for their intended use and is there evidence of compliance?

Yes, defects are analyzed using fishbone.

Yes, the record defect by type of defect.

Yes, there is a procedure for collected of defect found in quality system.

The sampling procedure requires review of sampling plans when changes occur.

No such procedure - Action in place.

Yes, there is a procedure for collection of defects during production, from incoming inspection and from client feedback. They are all documented.

Yes, there is a procedure for collection of defects from incoming inspection, and they are all documented.

No, the factory does not use statistical technique to determinate proper sampling plan for inspection or to detect capability of process.

Yes, there is a procedure for collected of defect during production, and they are all documented.

Is there a documented and properly implemented process for handling of customer complaints?

Is there evidence that the defect data is analyzed to identify opportunities for corrective or preventive action?

Does each defect have a unique and traceable identification number?

There is a procedure that documents the decision making process to pursue investigation and root cause corrective action.

8


Rev.AUDIT CHECKLIST



Report No.



B18.10

C

B18.11

C

B18.12

C

B18.14

C



Yes, records are available for two complaint received since March.

Results of corrective and preventive actions are reviewed during management review.

There is a documented rationale explaining why items/issues are not selected for further investigation.

There is evidence that the corrective and preventive action has been fully documented (problem statement, identified root cause and identification of action taken to eliminate root cause).

The evidence includes verification that the corrective action has fixed the root cause and resulted in no adverse effects.

Yes, actions are reviewed and approved by management for implementation, and their signature is visible in the record.

8

Supplier Name Audit Date Report No.XXXXXXXXXXX XX/XX/XXXX XXXXXXXX

ISO 9001 Quality System Audit Rev.FACTORY PHOTOS

Showroom Showroom

Photo Removed

Entrance gate Office

1. Quality policy and manual Showroom

8



1. Quality objective & goals 2. Record of customer satisfaction

Photo Removed

3. Organization chart 4. Nomination letter for management rep.

5. Last internal audit plan & scope5. Annual internal audit plan

8



Photo Removed

6. Internal auditor's certificate 7. Records of findings from internal audit

Record 8. Training record for topic #8

9. Defect pictures posted in workshops 10. Design planning

8



14. Record of supplies' qualification 15. Record of suppliers' monthly evaluation

12. Document distribution list 13. Qualified suppliers list

17. On-site work instruction16. Record of order review

8



21. Raw material warehouse, tool's warehouse, packaging material warehouse.

18. Automatic adhesive system and record of monitoring 19. Standard samples visible on-site

20. Red boxes to put non-conforming products

23. Record of process parameters22. Tooling identification

8



24. Calibration certificate for inspection equipment23. Record of process parameters

25. Work instruction for incoming inspection

26. Record of in-process inspection

25. Record of incoming inspection

27. Record of final inspection

8



28. Work instruction for outgoing inspection 28. Record of outgoing inspection

29. Area to store incoming material before inspection 30. Identification of material in warehouse

31. Storage and identification of semi-finished product31. Storage and identification of semi-finished product

8



35. Packaging and inspection 36. Finished product in warehouse

34. Defect data analysis 35. Packaging and inspection

20. Red boxes to put non-conforming products 33. Internal non-conforming list

example report - proqc.com€¦ · iso 9001 audit report ... audit checklist supplier name audit...

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